The present invention relates to the field of orthopedic splinting devices. More particularly, the present invention provides curable adhesive splints including a curable splinting layer and an exposed pressure sensitive adhesive for retaining the splint in position on a patient.
Immobilization of various portions of human and animal bodies is required to allow for proper healing of skeletal fractures or other injuries. Where the fracture is in a limb, e.g., arm or leg, immobilization techniques typically include wrapping the injured limb with a curable casting/splinting material that hardens to reduce the fracture and thus allow for proper healing.
Immobilization of smaller skeletal features, such as fingers (after fracture, ligament repair, etc.) or of oddly shaped skeletal features, such as noses, pose a more difficult challenge. Finger fractures may be reduced surgically by the insertion of pins, etc. Surgical intervention, however, results in soft-tissue trauma and the risk of post-surgery infection is present.
Finger fractures may also be immobilized by securing aluminum, wood or plastic strips to the finger by wrapping gauze and adhesive tape around the finger. Noses may be immobilized by using a curable material, e.g., plaster of Paris, shaped to provide the desired support.
In both situations, the immobilization techniques are cumbersome and difficult to accomplish. They require a care provider to assemble multiple individual components. In the case of finger splints, the care provider is required to position the splinting components as desired while simultaneously securing them in position. This combination of activities can prove difficult to accomplish without impairing the most effective positioning of the splints or their secure attachment, both of which can ultimately impact the effectiveness of the immobilization.
Another disadvantage is that, where aluminum or other metallic splints are used, the ability to monitor healing by radiography may be adversely impacted due to obstruction by the metallic splints.
An additional disadvantage is that the resulting splint constructions are bulky. The cumbersome finger splints may excessively impair the wearer""s ability to button or unbutton clothing, open and close buckles, wear gloves, and to accomplish tasks such as typing, etc. In the case of nasal splints, the patient""s ability to wear eyeglasses can be impaired. Furthermore, the cosmetic appearance can pose a barrier to effective use of the splint as patients may be motivated to remove the splint early because of appearance.
The present invention provides adhesive splints, methods of manufacturing the splints and methods of using the splints. The splints include a curable splinting layer and an exposed pressure sensitive adhesive proximate a first major side of the splinting layer. The pressure sensitive adhesive is used to secure the curable layer in position to provide the desired immobilization. The curable splinting layer may be of any material that can be shaped and cured to provide the desired level of stiffness required for immobilization, such as, e.g., moisture-curable splinting material, etc.
One advantage of the adhesive splints of the present invention is the ability to mold or form the splint to a desired shape while still providing the stiffness required for immobilization after curing. The shaped splinting layer can reduce the bulk of the finished splint.
Another advantage is that the splints may be provided as a one-piece, integral unit, thereby simplifying positioning and attachment of the splint as compared to known splinting techniques that use multiple individual components. For example, in some embodiments of the adhesive splints of the invention, the splinting layer may be attached directly to the patient""s skin, eliminating the need for an underlying layer of bandaging. In addition, the splinting layer is not separate from the materials used to secure the splint, thus preventing the need to hold the splint in place while wrapping it with adhesive tape.
In some embodiments, the splints allow for ambulation or micro-motion of, e.g., an immobilized finger, thereby reducing stiffness associated with total immobilization of the finger. As a result, the need for rehabilitation to restore complete range of motion after immobilization may be reduced. Although some small amount of motion may be allowed, such restraint is still considered xe2x80x9cimmobilizationxe2x80x9d as that term is used in connection with the present invention.
The adhesive splints of the present invention are also preferably radiolucent, thereby providing the opportunity to monitor the healing process without removing the splint.
The adhesive splints of the present invention may also preferably be manufactured of porous materials, thereby improving patient comfort during immobilization.
The adhesive curable splint of the present invention may optionally be provided in a package. In some instances, the curable splinting layer may include moisture-curable resin and the package may be moisture proof to prevent curing of the splint until desired.
In one aspect, the present invention provides a curable adhesive splint having an interior surface and an exterior surface, the splint including a curable splinting layer having first and second major sides, wherein the first major side of the splinting layer is proximate the interior surface of the splint; and exposed pressure sensitive adhesive proximate at least a portion of the interior surface of the splint, such that the splint can be adhesively attached to a patient""s skin.
In another aspect, the present invention provides a curable adhesive splint having an interior surface and an exterior surface, the splint including a backing layer proximate the exterior surface of the splint; a padding layer proximate the interior surface of the splint; a curable splinting layer retained between the backing layer and the padding layer; and exposed pressure sensitive adhesive on at least a portion of the interior surface of the splint, such that the splint can be adhesively attached to a patient""s skin.
In another aspect, the present invention provides a method of manufacturing an adhesive curable splint having an interior surface and an exterior surface by providing a curable splinting layer including first and second major sides, wherein the first major side is proximate the interior surface of the splint; providing exposed pressure sensitive adhesive proximate the interior surface of the splint, such that the splint can be adhesively attached to a patient. The method may optionally also include locating a padding layer over the first major side of the curable splinting layer; locating a backing layer over the second major side of the curable splinting layer; and retaining the curable splinting layer between the padding layer and the backing layer.
In another aspect, the present invention may provide a method of using a curable adhesive splint having an interior surface and an exterior surface by providing an adhesive splint including a curable splinting layer having first and second major sides, wherein the first major side of the splinting layer is proximate the interior surface of the splint, the splint further including exposed pressure sensitive adhesive proximate at least a portion of the interior surface of the splint; adhesively attaching the splint to a patient with the exposed pressure sensitive adhesive; and curing the curable splinting layer.
These and other features and advantages of the present invention are described more completely below with respect to illustrative embodiments of the invention.